Modified radical mastectomy: a pilot clinical trial comparing the use of conventional electric scalpel and harmonic scalpel

Abstract

Background: The aim of this study was to compare the rates of local postoperative complications among women undergoing modified radical mastectomy with an electric scalpel (ES) or a harmonic scalpel (HS). It is thought that HS use has less postoperative complications, mainly seroma formation.

Methods: This study was a prospective non-randomised clinical trial (NCT01391988) among consecutive patients, performed in parallel. Patients underwent modified radical mastectomy using an HS or ES. We analysed the following operative variables: time, blood loss and seroma volume drainage. Postoperative complications, including seroma, flap necrosis, haematoma and infection were evaluated on the 7th and 14th days.

Results: Forty-six patients underwent a MRM with ES and 49 with HS; no differences were observed between the groups. The rate of local complications was 29% in the HS group and 52% in the ES group (p = 0.024). The rates of seroma (16.3% versus 28.3%; p = 0.161), necrosis (4.1% vs. 21.7%; p = 0.013; OR = 0.15), haematoma (2.0% vs. 8.7%; p = 0.195) and infection (2.0% vs. 6.5%; p = 0.351) were lower in the HS group. Adding the findings of all comparative studies using HSs in MRM to the seroma rates in the current study, the seroma rate, expressed as a categorical variable, did not decrease with HS. Seroma was present in 60/219 cases using an HS and in 69/239 cases utilising an ES (p = 0.72). Based on a multivariate analysis, HS decreased the risk of skin necrosis (p = 0.015).

Conclusions: HSs do not decrease the seroma rate. However, this method may be useful in skin sparing mastectomy because it decreases skin flap necrosis.